Recruitment

Recruitment Status
Completed
Estimated Enrollment
94

Inclusion Criterias

Sub-optimal vitamin D status (<50nmol/L)
Impaired glucose tolerance (Fasting glucose <7.0 mmol/L (126mg/dl) and 2hr post-glucose load 7.8-11.0 mmol/L (140-199 mg/dl) or Impaired fasting glucose 5.6-6.9 mmol/L (100-125mg/dL) defined according to American Diabetes Association
Sub-optimal vitamin D status (<50nmol/L)
Impaired glucose tolerance (Fasting glucose <7.0 mmol/L (126mg/dl) and 2hr post-glucose load 7.8-11.0 mmol/L (140-199 mg/dl) or Impaired fasting glucose 5.6-6.9 mmol/L (100-125mg/dL) defined according to American Diabetes Association

Exclusion Criterias

Psychiatric problems
Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
Already taking vitamin D supplements > 10 µg/d
...
Psychiatric problems
Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
Already taking vitamin D supplements > 10 µg/d
Significant liver and renal disease (liver function tests >3x upper limit of normal and glomerular filtration rate <30ml/min)
Established cardiovascular disease
Excessive alcohol consumption (>28 Units/week men or >21 Units/week women)
History of kidney stones
Medical conditions or medications that could influence vitamin D metabolism
Pregnant or lactating
Diabetes mellitus
Hyperparathyroidism
Hypercalcaemia

Summary

Conditions
  • Insulin Resistance
  • Pre-diabetes
  • Sub-optimal Vitamin D Status
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

Sub-optimal vitamin D status (<50nmol/L)
Impaired glucose tolerance (Fasting glucose <7.0 mmol/L (126mg/dl) and 2hr post-glucose load 7.8-11.0 mmol/L (140-199 mg/dl) or Impaired fasting glucose 5.6-6.9 mmol/L (100-125mg/dL) defined according to American Diabetes Association
Sub-optimal vitamin D status (<50nmol/L)
Impaired glucose tolerance (Fasting glucose <7.0 mmol/L (126mg/dl) and 2hr post-glucose load 7.8-11.0 mmol/L (140-199 mg/dl) or Impaired fasting glucose 5.6-6.9 mmol/L (100-125mg/dL) defined according to American Diabetes Association

Exclusion Criterias

Psychiatric problems
Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
Already taking vitamin D supplements > 10 µg/d
...
Psychiatric problems
Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
Already taking vitamin D supplements > 10 µg/d
Significant liver and renal disease (liver function tests >3x upper limit of normal and glomerular filtration rate <30ml/min)
Established cardiovascular disease
Excessive alcohol consumption (>28 Units/week men or >21 Units/week women)
History of kidney stones
Medical conditions or medications that could influence vitamin D metabolism
Pregnant or lactating
Diabetes mellitus
Hyperparathyroidism
Hypercalcaemia

Locations

Belfast, N. Ireland, BT12 6BJ
Belfast, N. Ireland, BT12 6BJ

Tracking Information

NCT #
NCT01889810
Collaborators
  • HSC Research & Development Division, Public Health Agency, Northern Ireland
  • The Metabolic Unit Research Fund, The Royal Hospitals, Belfast, Northern Ireland
  • Northern Ireland Chest Heart and Stroke
Investigators
  • Principal Investigator: Michelle McKinley, PhD Queen's University, Belfast
  • Michelle McKinley, PhD Queen's University, Belfast